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Cocet
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref KFT-06/6943532400006Model KFT-01、KFT-02、KFT-03、KFT-04、KFT-05、KFT-05、KFT-07、KFT-08、KFT-09、KFT-10、KFT-11、KFT-12、KFT-13、KFT-14、KFT-15、KFT-16、KFT-17、KFT-18、KFT-19、KFT-20
Identity
- Trade Name
- COCET EUDAMEDFDA UDI
- Generic Name
- Continuous electronic patient thermometer, battery-powered FDA UDI
- Device Name
- Digital thermometer EUDAMED
- Model / Reference
- KFT-01、KFT-02、KFT-03、KFT-04、KFT-05、KFT-05、KFT-07、KFT-08、KFT-09、KFT-10、KFT-11、KFT-12、KFT-13、KFT-14、KFT-15、KFT-16、KFT-17、KFT-18、KFT-19、KFT-20 EUDAMEDKFT-06/6943532400006 EUDAMEDKFT-06 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06943532400006 EUDAMEDFDA UDI
- Basic UDI-DI
- 69435324DTCNMF000019108BL EUDAMED
- Direct Marketing DI
- 06943532400006 EUDAMED
- 510(k) Number
- K182652 FDA UDI
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- V0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) EUDAMED
- GMDN Term
- Continuous electronic patient thermometer, battery-powered FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Liquid Chemical FDA UDI
MR Safe FDA UDI
Cocet by Kangfu Medical Equipment Factory — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69435324DTCNMF000019108BL | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Kangfu Medical Equipment Factory
- EUDAMED SRN
- CN-MF-000019108
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (2)
- EUDAMED 3bd1cd16-3020-4e3f-9a83-753b9c0d71df 61 fields · synced Jun 20, 2026
- FDA UDI d53bc4b2-e2ab-4361-a491-e5dc58114f05 33 fields · synced May 29, 2026